Treatment Fluid Delivery Method, And Turbulator For Promoting Uptake Of A Treatment Agent

ABSTRACT

A turbulator for promoting mixing of fluids passing through a body lumen includes an elongate flow perturbing component and an elongate shape controlling component freely slidable within the flow perturbing component. The turbulator is adjustable from a low profile, lumen access configuration to a deployed configuration via sliding the shape controlling component within the flow perturbing component. Adjusting the turbulator within a body lumen of a patient induces turbulence within a flow of fluid passing through the body lumen to increase mixing of a treatment fluid with the body fluid by way of the induced turbulence.

TECHNICAL FIELD

The present disclosure relates generally to methods and mechanisms forintraluminal treatment of a patient, and relates more particularly topromoting mixing of a treatment fluid with a body fluid passing througha body lumen of a patient to a downstream treatment site.

BACKGROUND

A wide variety of medical procedures involve the supplying of atreatment fluid into a body lumen of a patient. Peripheral interventiontechniques in the human cardiovascular system represent one class ofmedical procedures where supplying of a treatment fluid is well knownfor a variety of purposes. For instance, thrombolytic agents arecommonly delivered by way of infusion into a vein or artery for thepurpose of breaking up and/or dissolving clot material. Anotherperipheral intervention procedure involves supplying a chemotherapeuticagent which may be carried by blood flow to a treatment site of interestsuch as a tumor. Peripheral intervention commonly entails percutaneousaccess to a patient's cardiovascular system. A great many differentdevices and techniques have been developed over the years forpercutaneously accessing treatment sites, and supplying treatment fluidssuch as the thrombolytic and chemotherapeutic agents mentioned above.Some of these strategies have met with great success in certaintreatment contexts, but improvements could be made in others.

Many body tissues are relatively insensitive to the effects of certaintreatment agents such as dyes, saline, and others. Other treatmentagents may be relatively toxic regardless of tissue type. Such toxicityis not entirely unintended, as in the case of chemotherapeutic agents.Chemotherapeutics are typically designed to kill tumor cells, but canoften also damage healthy tissue. While certain thrombolytic agentsmight not necessarily be considered “toxic,” they can have deleteriouseffects on various parts of the body such as by inducing bleeding. Thedesire to avoid overuse of certain treatment agents, and avoid theiradministration outside of target locations, will thus be readilyapparent. Such overuse or extraneous administration, however, remainsrelatively common due to at least in part to difficulty in accessingcertain parts of the body, difficulty in controlling flow of treatmentfluids in vivo, and incomplete uptake of treatment agents by targetedtissues.

SUMMARY OF THE DISCLOSURE

In one aspect, a method of delivering a treatment fluid to a treatmentsite within a body lumen of a patient includes, advancing a turbulatorincluding, a shaped controlling component having a dominant shape memoryproperty and a flow perturbing component having a subordinate shapedmemory property, through a body lumen. The method further includesadjusting the flow perturbing component from a lumen access shapedefined by the dominant shape memory property to an expanded shapedefined by the subordinate shape memory property, to increase turbulencein the flow of a body fluid through the body lumen. The method stillfurther includes introducing the treatment fluid into the body lumensuch that the treatment fluid and the body fluid are mixed by theincreased turbulence while flowing to the treatment site.

In another aspect, a turbulator for promoting mixing of fluids passingthrough a body lumen in a patient includes an elongate flow perturbingcomponent having a nonporous proximal segment and a porous distalsegment, the porous distal segment having a subordinate shape memoryproperty and including an exposed wire coil with a fixed primary shape,a fixed secondary shape, and a mutable tertiary shape. The turbulatorfurther includes an elongate shape controlling component freely slidablewithin the flow perturbing component between a distally advancedlocation, and a retracted location. The elongate shape controllingcomponent including a rigid proximal segment having a dominant shapememory property, and a non-rigid distal segment. The turbulator isadjustable from a low profile, lumen access configuration at which thedominant shape memory property defines the mutable tertiary shape, to anexpanded profile, deployed configuration at which the subordinate shapememory property defines the mutable tertiary shape, at least in part bysliding the shape controlling component from the distally advancedlocation to the retracted location.

In still another aspect, a method for promoting uptake of a treatmentagent during performing an intraluminal procedure on a patient includes,introducing a treatment fluid containing the treatment agent into a bodylumen of the patient having a body fluid flowing therethrough, andincreasing mixing of the treatment fluid with the body fluid viaadjusting an elongate wire turbulator from a lower turbulence inducingshape to a higher turbulence inducing shape within the body lumen. Themethod further includes perfusing a body tissue of the patient locatedat a downstream treatment site with the mixed treatment fluid and bodyfluid.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partially sectioned side diagrammatic view of a packagedintraluminal treatment system, according to one embodiment;

FIG. 2 is a sectioned side diagrammatic view of a portion of aturbulator, according to one embodiment;

FIG. 3 is a partially sectioned side diagrammatic view of a turbulatorin a deployed configuration, including a detailed enlargement, accordingto one embodiment;

FIG. 4 is a partially sectioned side diagrammatic view of a turbulatorin a deployed configuration, according to another embodiment;

FIG. 5 is a side diagrammatic view of a turbulator in a deployedconfiguration, according to yet another embodiment;

FIG. 6 is a side diagrammatic view of a turbulator in a deployedconfiguration, according to yet another embodiment;

FIG. 7 is a pictorial view of one stage of an intraluminal treatmentprocedure;

FIG. 8 is a pictorial view of another stage of the intraluminaltreatment procedure;

FIG. 9 is a pictorial view of yet another stage of the intraluminaltreatment procedure; and

FIG. 10 is a pictorial view of one stage of an intraluminal treatmentprocedure, according to another embodiment.

DETAILED DESCRIPTION

Referring to FIG. 1, there is shown an intraluminal treatment system 10according to one embodiment. System 10 may include a plurality ofdifferent components positioned within a sterile package 12, and beingconfigured for use in performing intraluminal treatment procedures asfurther described herein. Sterile package 12 may include a sealed,peel-open pouch in one embodiment. System 10 may include a turbulator 14for promoting mixing of fluids passing through a body lumen in apatient, a piercing needle 13, an introducer sheath 15 and an adaptersuch as a Y-fitting 68, sealed within package 12. Additional componentssuch as a conventional wire guide, and a microcatheter might also beincluded. As will be further apparent from the following description,system 10 may be uniquely adapted for use in certain procedures in whichimproved mixing of treatment fluids with body fluids is desired overwhat can typically be achieved using conventional systems.

Turbulator 14 may include an elongate flow perturbing component 16having a nonporous proximal segment 18, and a porous distal segment 20.Component 16 may include a proximal end 24 which includes a fitting ormanifold 25, and a distal end 26 having a distal tip 27. Tip 27 mayinclude a rounded, atraumatic shape. Distal segment 20 may include anexposed wire coil 22 having a fixed primary shape, a fixed secondaryshape, and a mutable tertiary shape. Distal segment 20 may furtherinclude a subordinate shape memory property, the significance of whichwill be further apparent from the following description.

Turbulator 14 may further include an elongate shape controllingcomponent 50 freely slidable within flow perturbing component 16 betweena distally advanced location, approximately as shown in FIG. 1, and aretracted location. Elongate shape controlling component 50 may includea rigid proximal segment 52 having a dominant shape memory property, anda non-rigid distal segment 54. In FIG. 1, a proximal end 56 of component50 is shown positioned outside of component 16, and a distal end 58 ofcomponent 50 is shown abutting tip 27, at the distally advanced locationmentioned above. Turbulator 14 may be adjusted from a low profile, lumenaccess configuration at which the dominant shape memory property definesthe mutable tertiary shape of exposed wire coil 22, to an expandedprofile, deployed configuration at which the subordinate shape memoryproperty defines the mutable tertiary shape, via sliding component 50from the distally advanced location to a retracted location.

To this end, component 16 may include an outer surface 17, and an innersurface 21 defining a control lumen 19 receiving component 50 coaxiallyand slidably therein. Referring also to FIG. 2, component 16 may furtherinclude a tubular fluid supply conduit 29 extending between fluid inlet30, and at least one fluid outlet 32 located in distal segment 20. Inone embodiment, supply conduit 29 may include a nonporous sheath 39extending from fluid inlet 30 to a proximal end 28 of exposed wire coil22. Sheath 39 may include an external sheath, comprised of a suitablematerial such as a fluoropolymer, heat shrunk about component 16 orattached by another suitable means. Control lumen 19 may continuouslytransition into a fluid passage 41 defined by fluid supply conduit 29.

In the embodiment shown, component 16 includes a helical wire 36extending through each of proximal segment 18 and distal segment 20. Inone embodiment, helical wire 36 may be formed into a constant pitchuniform diameter helical shape. Helical wire 36 includes exposed wirecoil 22 within distal segment 20, and defines a longitudinal helix axisH₁. Shape controlling component 50 may include a non-helical wire 60. Asmentioned above, one or more fluid outlets 32 may be formed in distalsegment 20. In one embodiment, the one or more fluid outlets 32 may bedefined by a plurality of wire turns 34 of exposed wire coil 22.Adjacent wire turns 34 may normally abut one another, but be slightlysqueezed apart by a pressure of fluid passed through fluid supplyconduit 29 and control lumen 19, as further described herein. In otherembodiments, helical wire 36 may be formed into a helical shape having avarying pitch, or non-uniform in diameter, or even having slots or thelike formed therein which define fluid outlets 32.

As mentioned above, FIG. 1 illustrates component 50 at a distallyadvanced location within component 16, at which distal tip 58 abuts oris adjacent to distal tip 27. When component 50 is positioned at thedistally advanced location within component 16, approximately as shownin FIG. 1, turbulator 14 may be understood to be in the low profile,lumen access configuration. When component 50 is retracted, turbulator14 may be understood to be in one of several possible expanded profile,deployed configurations. The low profile configuration facilitatesadvancing turbulator 14 through a body lumen in a patient during or inpreparation for performing an intraluminal treatment procedure, whereasthe expanded profile configuration enables inducement of turbulencewithin the body lumen in a manner further described herein for promotingmixing of fluids within the body lumen.

In FIG. 2, component 50 has been slid in a distal to proximal directionrelative to the state shown in FIG. 1, but has not yet been slid farenough to enable the full deployment of turbulator 14, and thus the FIG.2 illustration may be understood as an intermediate configurationbetween low profile and fully expanded profile configurations. It may benoted that a shape of component 16 as depicted in FIG. 2 has changedfrom a shape depicted in FIG. 1. It may also be noted that axis H₁ and asecond longitudinal axis T₁ defined by fluid passage 41 have changedfrom a collinear state shown in FIG. 1, to a partially overlapping butpartially divergent state shown in FIG. 2. In the low profileconfiguration, component 16 may be understood to be radially condensedrelative to axis T₁. As used herein, the term “radially condensed” meansthat a radius of a circle having a center within longitudinal axis T₁and a perimeter tangent to a radially outermost point of component 16,e.g. tangent to radially outermost points of outer surface 17, isrelatively small. In the configuration shown in FIG. 2, component 16 maybe understood to be radially expanded relative to axis T₁. “Radiallyexpanded” means that the radius described above is relatively large. Thechange in shape in component 16 which is evident from comparing FIG. 1with FIG. 2, and more dramatic changes in shape as further describedherein, results at least in part from the differing shape memoryproperties of component 16 versus component 50 mentioned above.

In one practical implementation strategy, the dominant shape memoryproperty of component 50 may define a shape of distal segment 20 at thedistally advanced location of component 50. At a retracted location ofcomponent 50 as shown in FIG. 2, distal segment 20 has begun to assume ashape which is defined by the subordinate shape memory property. Atprogressively more retracted locations of component 50, relatively moreof segment 20 may assume a shape defined by the subordinate shape memoryproperty. Another way to understand the relationship between therespective shape memory properties is that the dominant shape memoryproperty may define a shape of any portion of component 16 within whichcomponent 50 is presently positioned, subject to certain exceptionsdescribed herein. Portions of component 16 within which component 50 isnot presently positioned may have a shape defined by the subordinateshape memory property. In the example embodiments described herein,component 50 includes a rest state which defines a generally linearshape. Thus, when no external deforming force is applied to shapecontrol component 50, it may be expected to assume a generally linearconfiguration. Portions of component 16 within which component 50 ispresently positioned may likewise be expected to assume a generallylinear shape in response to the dominant shape memory property.

Component 16 may further be understood to be in a biased state in thelow profile configuration, where the dominant shape memory property isat least predominantly responsible for determining its shape. Asmentioned above, in the biased state component 16 may have a generallylinear shape. Component 16 may also include a rest state, assumed whencomponent 50 has been retracted, which includes a non-linear, orcurvilinear, shape. Thus, in the lumen access configuration as depictedin FIG. 1, component 16 may be generally linear to facilitate access oradvancing through a body lumen, but may have a non-linear shape in thedeployed configuration for purposes which will be apparent from thefollowing description. It will further be understood that the biasedstate of component 16 may include a state in which helical wire 36 isradially condensed relative to axis T₁. It will still further beunderstood that the rest state of component 16 may include a state inwhich wire 36 is radially expanded relative to axis T₁.

It will be recalled that distal segment 54 of component 50 may benon-rigid relative to proximal segment 52. A dashed line J in FIG. 2denotes one example location where component 50 transitions from rigidto non-rigid in a proximal to distal direction. Accordingly, in thestate depicted in FIG. 2 a shape of distal segment 54 is in factdetermined by a shape of component 16. Thus, while proximal segment 52of component 50 is relatively rigid, and thus includes the dominantshape memory property, distal segment 54 may be relatively soft orfloppy, and thus have a different shape memory property than the rest ofcomponent 50. This aspect of the present disclosure allows for component50 to track relatively readily through component 16 during sliding, andin particular during advancing component 50 in a proximal to distaldirection to radially condense component 16 as further described herein.Another way to understand this configuration, is that a majority of anaxial length of component 50 may have the dominant shape memory propertyand thus determine a shape of component 16 when positioned therein, buta relatively short portion of component 50 extending proximally fromdistal end 58 may in fact not include the dominant shape memoryproperty, hence the illustration in FIG. 2 of distal end 58 curving inresponse to curving of component 16 away from axis T₁. A distal-mostportion of component 16, adjoining end 26, may also be relatively softor floppy, compared to the rest of distal segment 20. Thus, distalsegment 54 of component 50 might have a shape memory property which isdominant relative to a shape memory property of distal segment 20 neardistal end 26, but subordinate to other parts of distal segment 20. Onthe whole, at least a majority of distal segment 20 of component 16 willhave a shape memory property characterized as “subordinate,” while atleast a majority of component 50 will have a shape memory propertycharacterized as “dominant.” It should be understood in any event thattertiary shape control according to the present disclosure willtypically occur via the tendency of component 50 to straighten component16 by contacting inner surface 21, i.e. applying forces in a vectordirection transverse to axis H₁. This contrasts with strategies in whicha stiff core wire is used to straighten an outer sheath via axialforces, although such strategies may still fall within the scope of thepresent disclosure.

Referring also now to FIG. 3, there is shown turbulator 14 wherecomponent 50 has been further refracted within component 16 relative tothe state shown in FIG. 2. A relatively greater axial length ofcomponent 16 now assumes a shape defined by the subordinate shape memoryproperty. As mentioned above, component 16 may include wire turns 34.Wire turns 34 correspond to individual turns of helical wire body 36,about helix axis H₁. Component 16 may also include a plurality of bodyturns 40 about longitudinal axis T₁. Wire turns 32 may thus beunderstood to define a minor curving shape about axis T₁, which mayinclude a spiral shape, whereas body turns 40 may be understood todefine a major curving shape about axis T₁, which may also include aspiral shape. In one embodiment, body turns 40 may be non-uniform insize and/or shape. To this end, body turns 40 may include each of asmall radius turn, for example the lowermost turn in FIG. 3, and one ormore large radius turns, each of the small and large radius turns beingcircumferential of axis T₁.

As discussed above, the shape of turbulator 14, and in particular flowperturbing component 16, which may be varied by sliding component 50therein may be understood as a mutable tertiary shape, and component 16may also be understood to include a fixed primary shape, and a fixedsecondary shape. The terms “primary shape,” “secondary shape,” and“tertiary shape,” are used herein in a manner analogous to similar termsused to describe hierarchical shapes of certain biomolecules such asproteins. Thus, the primary shape of component 16 may be understood as alow level shape, the secondary shape may be understood as a middle levelshape, and the tertiary shape may be understood as a high level shape.Stated yet another way, the fixed primary shape may be a basic shape ofhelical wire 36 from which component 16 is formed, the fixed secondaryshape may be understood as a shape into which wire 36 is wound, and themutable tertiary shape may be understood as a shape which the wound wire36 assumes under the varying conditions described herein.

FIG. 3 illustrates still further geometric attributes of turbulator 14associated with the primary, secondary, and tertiary shapes. Helicalwire 36 may further define a primary axis P which is internal to helicalwire 36. Primary axis P may include a longitudinal center axis ofhelical wire 36. The fixed primary shape of component 16 may include across sectional shape of helical wire 36 in two dimensions defined byprimary axis P. In the illustrated embodiment, the fixed primary shapemay include a rounded cross-sectional shape such as a circular shape inthe plane of the page of FIG. 3. The two dimensions Y₁ and X₁ defined byprimary axis P are perpendicular to one another and each intersectprimary axis P, and are oriented perpendicular to primary axis P. Acircular fixed primary shape represents one practical implementationstrategy, however, in other embodiments a non-circular shape such as anoval shape or a polygonal shape might be used, for example. Helical wire36 may further define a secondary axis which includes axis H₁. Axis H₁may be external to helical wire 36 and internal to wire turns 34. Thesecondary shape may include a fixed secondary shape in three dimensionsdefined by axis H₁, such as the minor curving shape of helical wire 36mentioned above. In FIG. 3, the three dimensions defined by secondaryaxis H₁ are shown as dimensions X₂, Y₂ and Z₂, and the fixed secondaryshape includes a helical shape with axis H₁ comprising a helix centeraxis overlapping with dimension Z₂.

Helical wire 36 may still further define a tertiary axis, which in FIG.3 is collinear with axis T₁ and commonly labeled therewith. The tertiaryaxis may include a geometric center axis of component 16. Thus, thetertiary axis may be defined by geometric center points of the tertiaryshape of component 16 proceeding in a proximal to distal direction.Although the tertiary axis may intersect wire 36 and wire turns 34 atcertain locations, at least a majority of the tertiary axis may beexternal to wire 36 and external to wire turns 34 when component 16 isin the rest state and turbulator 14 is in the expanded profileconfiguration approximately as shown in FIG. 3. Referring back to FIG.1, it may be appreciated that the tertiary axis T₁ may be external towire 36 and internal to wire turns 34 when component 16 is in the biasedstate and turbulator 14 is in the low profile configuration.

The tertiary shape of component 16 may include a shape of wire 36 inthree dimensions defined by the tertiary axis T₁, and labeled X₃, Y₃,and Z₃ in FIG. 3. The mutable tertiary shape may further include a majorcurving shape such as a spiral or helical shape in dimensions X₃, Y₃ andZ₃. The tertiary shape may further include a lower turbulence inducingshape in the low profile, lumen access configuration, and a higherturbulence inducing shape in the expanded profile, deployedconfiguration. The higher turbulence inducing shape may include at leastone turn about axis T₁. The at least one turn may correspond to bodyturns 40, and in the FIG. 3 embodiment the tertiary shape includes atotal of five body turns 40 about axis T₁; however, a different numberof body turns may be used depending upon the application. As usedherein, the term “helical” shape is intended to refer to a type ofspiral shape. Thus, the tertiary shape shown in FIG. 3 may be understoodas a curving shape, and a spiral shape, but not a helical shape. Thetertiary shape shown in FIG. 3 may also be understood as having adistally expanding taper.

Also shown in FIG. 3 are several dimensional attributes of turbulator14. In particular, a primary dimension D₁ corresponding to an outerdiameter or wire thickness of wire 36 is shown, and may be equal tobetween about 2/1000ths inches or 0.05 millimeters, and about 3/10000thsinches or 0.08 millimeters in one embodiment. A secondary dimension D₂corresponding to an outer diameter dimension of a coil or helix intowhich wire 36 is wound is also shown in FIG. 3, and may be less thanabout 20/1000ths inches or 0.51 millimeters, and further may be equal tobetween about 11/1000ths inches or 0.28 millimeters and about 18/1000thsinches or 0.46 millimeters in one embodiment. In one further embodiment,dimension D₁ may be equal to about 2/1000ths inches, and dimension D₂may be equal to about 11/1000ths inches. In still another embodiment,dimension D₁ may be equal to about 3/1000ths inches and dimension D₂ maybe equal to between about 15/1000ths inches or 0.38 millimeters andabout 18/1000ths inches.

Another dimension D₃ is shown in FIG. 5 and corresponds to a mutableouter diameter dimension in a direction perpendicular to andintersecting axis T₁, and extending between radially outermost points ofdistal segment 20 relative to axis T₁. Dimension D₃ may be equal toabout 118/1000ths inches or about 3 millimeters in one embodiment. Froma maximum width equal to D₃, the tertiary shape depicted in FIG. 3 maytaper in a proximal direction to another mutable outer diameterdimension D₅ of about 79/1000ths inches or about 2 millimeters,approximately halfway between the body turns 40 indicated first andsecond from the bottom in FIG. 3. In one further embodiment, D₃ may beequal to less than about 20/1000ths inches in the lumen accessconfiguration, and greater than about 20/1000ths inches and less thanabout 118/1000ths inches in the deployed configuration. Still anotherdimension D₄ is shown in FIG. 3, and represents an outer diameter orwire thickness of wire 50. D₄ may be equal to between about 5/1000thsinches or about 0.13 millimeters and about 7/1000ths inches or about0.18 millimeters, in one embodiment. In one further example embodiment,D₄ may be equal to at least about 33%, and may be equal to 40% orgreater, of D₂.

As used herein, “about” 2 millimeters may be understood as equal tobetween 1.5 and 2.4 millimeters. “About” 2/1000ths inches may beunderstood to be between 1.5/1000ths inches and 2.4/1000ths inches, andso on. It should further be appreciated that the mutable dimensions willtypically vary depending upon where component 50 is axially positionedwithin component 16. It may thus be appreciated that a range of length,width, height, shape, etc., of component 42 may be available, and aclinician manipulating turbulator 14 as further described herein maychoose to utilize a shape and/or dimensions of component 16 in vivowhich need not be specifically determined until the associated procedureis being performed. It may thus be appreciated that certain componentshapes and dimensions may have essentially infinite adjustability.

Turning now to FIG. 4, there is shown a turbulator 114 according toanother embodiment. Turbulator 114 includes an elongate flow perturbingcomponent 116 having a proximal segment 118 and a distal segment 120which includes a helical wire. Turbulator 114 may further include anelongate shape controlling component 150 which may include a non-helicalwire. Component 114 may include a fixed primary shape, a fixed secondaryshape, and a mutable tertiary shape, and is adjustable in a mannersimilar to that described above in connection with turbulator 14.Turbulator 14 is shown as it might appear in a deployed configuration,in which a secondary axis H₂ curves about a tertiary axis T₂, forexample in a spiral pattern. Turbulator 114 may be similar in manyrespects to turbulator 14 described above, but rather than a distallyexpanding taper, component 316 may be configured to assume a roughlydiamond tertiary shape, having body turns 140 which are of largerdiameter at a middle location, and smaller diameter at distal andproximal locations of segment 120. Thus, the tertiary shape of component116 may be understood as bidirectionally tapered in an expanded profile,deployed configuration.

Referring to FIG. 5, there is shown a turbulator 214 according to yetanother embodiment. Turbulator 214 includes an elongate flow perturbingcomponent 216 having a proximal segment 218 and a distal segment 220which includes a helical wire. Turbulator 214 may further include anelongate shape controlling component 250 which may include a non-helicalwire. Component 214 may include a fixed primary shape, a fixed secondaryshape, and a mutable tertiary shape, and is adjustable in a mannersimilar to that described above in connection with the foregoingembodiments. Turbulator 214 is shown as it might appear in a deployedconfiguration in which a secondary axis H₃ curves about a tertiary axisT₃, in a helical pattern. Turbulator 214 may also be similar in manyrespects to the foregoing embodiments, but rather than a taperingtertiary shape, component 216 may be configured to assume a uniformdiameter helical shape having a plurality of uniform diameter body turns240.

Turning to FIG. 6, there is shown a turbulator 314 according to yetanother embodiment, and including an elongate flow perturbing component316 and an elongate shape controlling component 350. Turbulator 14 isalso similar in many respects to the embodiments described above, butincludes a complex tertiary shape. Component 316 includes a proximalsegment 318 and a distal segment 320 defining a secondary axis H₄, and atertiary axis T₄. It may be noted that the tertiary shape of theembodiment of FIG. 6 includes a plurality of body turns 340 abouttertiary axis T₄.

A variety of materials and manufacturing techniques may be used inconstructing turbulators, wire guides, and components thereof inaccordance with the present disclosure. Techniques are known wherebywires and wire coils of metallic materials such as stainless steel,Nitinol®, and other metallic materials may be treated to impart a rangeof shape memory properties, and a wide variety of shapes assumed whenthe wires and wire coils are in a rest state. A variety of techniquesare also known whereby the dominant shape memory property associatedwith shape controlling components 50, 150, 250, 350 and the subordinateshape memory properties associated with flow perturbing components 16,116, 216, 316, may be established. For example, components 50, 150, 250,350 might be formed from a metallic material having a relatively greaterstiffness than material from which components 16, 116, 216, 316 may beformed. Processing techniques such as heat treating may be used wherebywire stiffness of the different wires is tailored to achieve a dominantversus subordinate shape memory property, or varying shape memoryproperties within a single wire such as the different rigidity ofsegments 52 and 54 in turbulator 14. In still further examples,differing gauge and/or shape of the wire used to manufacture components50, 150, 250, 350 versus components 16, 116, 216, 316, could impart thedesired differing shape memory properties.

INDUSTRIAL APPLICABILITY

Referring to the drawings generally, but in particular now to FIG. 7,there is shown intraluminal treatment system 10 as it might appear atone stage of a treatment procedure according to the present disclosure.It will be recalled that turbulator 16 may include a fitting or manifold25 configured to connect with an adapter such as Y-fitting 68,approximately as shown in FIG. 7. A fluid supply 70 is connected withY-fitting 68 to enable the supplying of a treatment fluid such as achemotherapeutic agent to a body lumen of a patient, by way of fluidpassage 41 and control lumen 19. System 10 is also shown as it mightappear having been placed by way of percutaneous access to a patient'scardiovascular system. Access for certain procedures contemplated hereinmay include femoral or brachial access, for example for treating akidney tumor, however, the present disclosure is not thereby limited.Introducer 15 passes through the patient's skin, and turbulator 14extends through the vasculature to a point at which tip 27 is positionedupstream of a treatment site such as a tumor, denoted via referencenumeral Q. In FIG. 7, arrows B denote an approximate anterogradedirection of blood flow within a vascular lumen V, and it may be notedthat blood is flowing downstream past turbulator 14 to treatment site Q.In one embodiment, turbulator 14 may be used as a wire guide which isadvanced through vascular lumen V to a desired location upstream oftreatment site Q. In other embodiments, turbulator 14 might be placed byway of a placement sheath, or passed through a microcatheter or thelike. A conventional wire guide might also be employed to reach adesired location within the vasculature, and then a placement sheathpositioned via the conventional wire guide, the wire guide removed, andthen turbulator 14 advanced through the vasculature to the desiredlocation. Where additional components such as a conventional wire guideand microcatheter are included in package 12, a clinician could selectone of several different options for placement of turbulator 14. Thoseskilled in the art will thus appreciate that a variety of differentplacement strategies might be employed, and the present disclosure isnot limited to any particular one. Moreover, since turbulator 14 mayfunction as a wire guide, it may be used in procedures different fromthose described herein.

In FIG. 7, a handle 72 is attached to component 50, and enables aclinician to manipulate turbulator 14 within vascular lumen V. It willalso be recalled that component 50 is not attached to component 16, andfreely slidable therein to adjust component 16 between a lowerturbulence inducing shape and a higher turbulence inducing shape. Withturbulator 14 positioned approximately as shown in FIG. 7, component 50may be slid relative to component 16 between a first location at whichthe dominant shape memory property of component 50 imparts the lowprofile, lumen access configuration, and a second location at which thesubordinate shape memory property of component 16 imparts the expandedprofile, deployed configuration. Sliding component 50 relative tocomponent 16 might take place by pulling component 50 in a distal toproximal direction. Alternatively, or in combination with pullingcomponent 50, component 16 might be pushed in a proximal to distaldirection to advance component 16 beyond component 50. One practicalimplementation strategy includes holding component 16 relativelystationary, and pushing component 16 in the proximal to distaldirection. This particular technique is believed to assist a clinicianin accurately positioning component 16 at a desired deployment locationwithin vascular lumen V, typically with the assistance of radiography.Regardless of whether pushing, pulling, or a combination is used,component 50 may be repositioned such that its dominant shape memoryproperty no longer defines the tertiary shape of component 16, andinstead the tertiary shape is defined by the subordinate shape memoryproperty. In one embodiment, component 50 may be completely removed fromthe patient when turbulator 14 is deployed.

Referring also to FIG. 8, there is shown turbulator 14 as it mightappear after component 16 has been adjusted to the expanded profile,deployed configuration. In FIG. 8, a treatment fluid such as achemotherapeutic agent is being supplied into vascular lumen V by way offluid supply conduit 29. In particular, the treatment fluid shown viaarrows C is being effused into vascular lumen V by way of fluid outlets32. Treatment fluid flowing from conduit 29 into distal segment 20 maytend to lose pressure as the fluid travels more distally. At least forconstant pitch, uniform wire coil embodiments, the loss in pressure maybe expected to result in a relatively greater effusion rate and amountin more proximal portions of exposed wire coil 22 versus more distalportions. For this reason, arrows C are shown relatively denser inregions of distal segment 20 adjacent proximal segment 18, andrelatively less dense in more distal regions. It should be appreciated,however, that porosity of segment 20 might be tailored to promoteuniform or non-uniform effusion of treatment fluid C.

Certain tumors and other areas of undesired tissue within a patient mayhave a relatively complex vasculature. Numerous small blood vessels mayform a fairly chaotic blood supply network within such body tissues. Itis believed that this relatively un-ordered vascular structure canrender certain tissues such as tumors relatively insensitive to certaintreatment techniques, such as treatment with a mixture of treatmentfluid and body fluid. For example, where a treatment fluid is suppliedby way of perfusion to the vasculature of a tumor, relatively poormixing of a treatment agent such as a chemotherapeutic agent in theblood can result in certain parts of the tumor receiving an inordinateproportion of the treatment agent, while other parts of the tumorreceive little, if any. This phenomenon is believed to be due at leastin part to a relatively laminar flow of blood and thus treatment fluidthrough a vascular lumen upstream of the treatment site. When the bloodarrives at the tumor, certain parts of the tumor vasculature maydisproportionally receive the chemotherapeutic agent. This potentiallyreduces the effectiveness of the chemotherapy procedure, or may requireexcessive quantities of chemotherapeutic agent, or long treatmentdurations. It has long been recognized that oversupply of treatmentfluid to a targeted body tissue can result in excess treatment fluidflowing to downstream body tissue, and having various deleteriousaffects. The present disclosure enables the promoting of uptake of atreatment agent during performing a procedure on a patient, such thatthe effectiveness of the treatment agent on target tissue is increased,while supplying of the treatment agent to tissues downstream from thetreatment site is reduced. These advantages are made possible by way ofperturbing laminar flow to induce turbulence in the flow of body fluidpassing distal segment 20. As a result, increased mixing of thetreatment fluid and the body fluid is possible in comparison to whatmight otherwise occur using conventional techniques.

It will be recalled that adjusting turbulator 14 from the low profileconfiguration to the expanded profile configuration adjusts distalsegment 20 from a lower turbulence inducing shape, to a higherturbulence inducing shape within a body lumen such as vascular lumen V.In particular, adjusting the mutable tertiary shape of distal segment 20can increase tortuosity of a fluid flow path through vascular lumen V.Referring now to FIG. 9, it may be noted that a flow of body fluid Bupstream of distal segment 20 is relatively uniform and, hence,relatively laminar. This upstream region is denoted as zone F. A secondzone G of vascular lumen V is also shown, and corresponds approximatelyto a portion of lumen V within which distal segment 20 has the higherturbulence inducing shape. It may be noted that the flow of blood andtreatment fluid in zone G is relatively non-uniform, and the blood andtreatment fluid may flow over, about, and through distal segment 20.Flow of body fluid and treatment fluid may also proceed around distalsegment 20, through gaps defined by body turns of distal segment 20 andan inner wall of vascular lumen V. Relatively laminar fluid flow throughzone F changes to relatively turbulent flow through zone G, andcontinuing downstream from zone G. Thus, increased mixing may occurwhile the body fluid and treatment fluid are passing turbulator 16, andalso while continuing to flow downstream thereof. Within treatment siteQ, a relatively greater proportion of the vasculature within thetreatment site is perfused via mixed treatment agent and blood than whatwould be expected with a conventional approach. Downstream of treatmentsite Q, little, if any, treatment agent is evident.

A typical chemotherapeutic treatment such as a treatment of a tumorwithin a kidney or other organ may be a relatively short procedure,where the treatment fluid is supplied for a time less than thirtyminutes. To conclude treatment, a clinician will typically takeappropriate steps to cease supplying the treatment fluid, and removewhatever devices from the patient which can be removed. Turbulator 14may be removed from vascular lumen V after ceasing supplying thetreatment agent at least in part by radially condensing distal segment20, for example by sliding component 50 relative to component 16 backtoward the distally advanced location within component 16, or by pushingcomponent 50 in a proximal to distal direction, or by a combination ofthe two. A sheath or the like may also be used to collapse or otherwiseradially condense turbulator 14. Once turbulator 14 has been partiallyor completely returned to a low profile lumen access configuration, itmay be removed from the patient and other appropriate post-proceduralactivities undertaken.

Referring now to FIG. 10, there is shown a turbulator 14 similar oridentical to the embodiment described above, but used in a differentmanner. In the procedure depicted in FIG. 10, a microcatheter or thelike 100 is positioned within the patient, and defines a longitudinallyextending lumen 108 within which turbulator 14 is positioned. By way oflumen 108, or a second lumen, treatment agent may be supplied via one ormore ports 110 formed in catheter 100 and fluidly connecting with lumen108. In the version shown in FIG. 10, treatment agent may be suppliedthrough catheter 100 instead of or in addition to being supplied throughturbulator 14, and the overall procedure may otherwise take place in asimilar manner.

The present description is for illustrative purposes only, and shouldnot be construed to narrow the breadth of the present disclosure in anyway. Thus, those skilled in the art will appreciate that variousmodifications might be made to the presently disclosed embodimentswithout departing from the full and fair scope and spirit of the presentdisclosure. For example, certain embodiments described herein may berelatively small, well-suited to small vascular lumens. The presentdisclosure is not limited in this regard, however, and relatively largerturbulator designs are contemplated herein. Thus, the present teachingsmay be expected to scale up or down. Moreover, a great many tertiaryshapes for deployed turbulators beyond those specifically illustratedherein might be used. For instance, a turbulator might be designed suchthat its flow perturbing component assumes a 2-dimensional coil whendeployed, in contrast to the 3-dimensional shapes shown herein. Otheraspects, features and advantages will be apparent upon an examination ofthe attached drawings and appended claims.

What is claimed is:
 1. A turbulator for promoting mixing of fluidspassing through a body lumen in a patient comprising: an elongate flowperturbing component including a proximal segment and a porous distalsegment, the porous distal segment having a subordinate shape memoryproperty and including an exposed wire coil with a fixed primary shape,a fixed secondary shape, and a mutable tertiary shape; and an elongateshape controlling component freely slidable within the flow perturbingcomponent between a distally advanced location, and a retractedlocation, the elongate shape controlling component including a rigidproximal segment having a dominant shape memory property, and anon-rigid distal segment; the elongate shape controlling component beingpositioned at the distally advanced location such that the turbulator isin a low profile, lumen access configuration at which the dominant shapememory property defines the mutable tertiary shape and the shape of thenon-rigid distal segment is determined by the shape of the flowperturbing component; and the turbulator further being adjustable to anexpanded profile, deployed configuration at which the subordinate shapememory property defines the mutable tertiary shape, at least in part bysliding the shape controlling component from the distally advancedlocation to the retracted location, to increase turbulence in the flowof a body fluid through the body lumen for mixing a treatment fluidtherewith while flowing to a treatment site.
 2. The turbulator of claim1 wherein the flow perturbing component further includes a tubular fluidsupply conduit extending between a fluid inlet located in the proximalsegment and at least one fluid outlet located in the porous distalsegment, the at least one fluid outlet being defined by a plurality ofwire turns of the exposed wire coil.
 3. The turbulator of claim 2wherein the flow perturbing component includes a helical wire extendingthrough each of the proximal segment and the distal segment thereof, thehelical wire including the exposed wire coil and defining a longitudinalhelix axis, and wherein the shape controlling component includes anon-helical wire positioned coaxially within the helical wire.
 4. Theturbulator of claim 3 wherein: the fixed primary shape includes acircular cross sectional shape of the helical wire, and the fixedsecondary shape includes a helical shape of the helical wire; the fluidsupply conduit defines a longitudinal passage axis collinear with thehelix axis, in the lumen access configuration; and the mutable tertiaryshape includes a radially condensed shape of the exposed wire coilrelative to the longitudinal passage axis, in the lumen accessconfiguration.
 5. The turbulator of claim 4 wherein the mutable tertiaryshape includes a plurality of body turns of the helical wire about thelongitudinal passage axis, in the deployed configuration.
 6. Theturbulator of claim 5 wherein the plurality of body turns includes eachof a small radius turn and a large radius turn which are circumferentialof the longitudinal passage axis.
 7. The turbulator of claim 2 whereinthe tubular fluid supply conduit includes a nonporous sheath extendingfrom the fluid inlet to a proximal end of the exposed wire coil.
 8. Theturbulator of claim 7 wherein the nonporous sheath includes an externalsheath attached to the helical wire.